Omeros (NASDAQ:OMER) reported updated data from its pivotal clinical trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.
All 28 patients have completed treatment and trial enrollment has been closed.
The study’s primary endpoint is complete response rate, with an FDA-agreed efficacy threshold of 15%. The updated results from the trial demonstrate a 54% complete response rate in patients who received at least one dose of narsoplimab, and a 65% complete response rate in patients who received at least four weeks of dosing.
“The non-clinical sections of our BLA have been submitted, our CMC campaign is progressing well with process validation and commercial lots already manufactured, and our pivotal trial is complete,” Dr. Gregory Demopulos, Omeros’ chairman and CEO, said in a statement.
“We’re very pleased that the response rates and confidence intervals seen with narsoplimab are well above [the FDA-agreed] efficacy threshold,” he added.
